Flex

Main information

  • Trade name:
  • Flex Shoulder System Aequalis Humeral Head - Humeral head prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Flex Shoulder System Aequalis Humeral Head - Humeral head prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218733
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218733

Tornier Pty Ltd - Flex Shoulder System Aequalis Humeral Head - Humeral head prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Tornier Pty Ltd

Postal Address

PO Box 230,BELROSE, NSW, 2085

Australia

ARTG Start Date

20/12/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Tornier SAS

161 Lavoisier

, Montbonnot St Martin, 38330

France

Products

1. Flex Shoulder System Aequalis Humeral Head - Humeral head prosthesis

Product Type

Single Device Product

Effective date

20/12/2013

GMDN

48088 Humeral head prosthesis

Functional description

Attached to the humeral stem component, it is intended for shoulder hemiarthroplasty (if the natural

glenoid provides a sufficient bearing surface), or as part of a total shoulder replacement (in conjunction

with a glenoid component). The humeral head is made from cobalt chrome alloy.

Intended purpose

A component of the Aequalis Ascend Flex Shoulder System intended for use as a replacement of shoulder

joints in primary anatomic, and a replacement of other shoulder joints devices in case of revisions if

sufficient bone stock remains.

Variant information

Diameter (mm) 37 - 54

Offset 1.5 - 4 mm

Height (mm) 13.5 - 27

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 09:30:51 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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